Azacitidine

Generic Name: Azacitidine

Brand Names: Onureg, Vidaza, Azacitidine Accord, Azacitidine betapharm, Azacitidine Mylan, Azacitidine Kabi

Drug Type: Small Molecule

Chemical Formula: C_₈H_₁₂N_₄O_₅

CAS Number: 320-67-2

Unique Ingredient Identifier: M801H13NRU

Background: Azacitidine is a pyrimidine nucleoside analogue with anti-neoplastic activity. It differs from cytosine by the presence of nitrogen in the C5-position, key in its hypomethylating activity. Two main mechanisms of action have been proposed for azacitidine. One of them is the induction of cytotoxicity. As an analogue of cytidine, it is able to incorporate into ...

Indication: Azacitidine (for subcutaneous or intravenous use) is indicated for the treatment of adult patients with the following French-American-British (FAB) myelodysplastic syndrome (MDS) subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemi...

Associated Conditions: Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Refractory Anemia, Refractory Anemia With Excess Blasts in Transformation, Refractory Anemia With Excess of Blasts (RAEB), Refractory Anemia With Ringed Sideroblasts, Newly diagnosed Juvenile Myelomonocytic Leukaemias (JMML)

Associated Therapies: -

Clinical Trials

Bortezomib and Azacitidine in Treating Patients With Relapsed or Refractory T-Cell Lymphoma

Phase 1

Completed

Conditions: Prolymphocytic Leukemia
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Small Intestine Lymphoma
T-cell Large Granular Lymphocyte Leukemia
Angioimmunoblastic T-cell Lymphoma
Hepatosplenic T-cell Lymphoma
Peripheral T-cell Lymphoma

Interventions: Drug: azacitidine
Drug: bortezomib
Procedure: Correlative studies

First Posted Date: 2010-05-24

Last Posted Date: 2013-12-03

Lead Sponsor: Pierluigi Porcu

Target Recruit Count: 8

Registration Number: NCT01129180

Locations: 🇺🇸
Ohio State University Medical Center, Columbus, Ohio, United States

Epigenetic Modulation in Relapsed/Refractory Follicular Lymphoma and Marginal Zone Lymphoma

Phase 2

Terminated

Conditions: Follicular Lymphoma
Marginal Zone Lymphoma

Interventions: Drug: azacitidine
Drug: lenalidomide

First Posted Date: 2010-05-12

Last Posted Date: 2016-09-12

Lead Sponsor: Duke University

Target Recruit Count: 11

Registration Number: NCT01121757

Locations: 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

Study of 5-azacitidine in Combination With Vorinostat in Patients With Relapsed or Refractory Diffuse Large b Cell Lymphoma (DLBCL)

Phase 1

Completed

Conditions: Lymphoma

Interventions: Drug: azacytidine
Drug: vorinostat

First Posted Date: 2010-05-11

Last Posted Date: 2017-04-10

Lead Sponsor: Weill Medical College of Cornell University

Target Recruit Count: 17

Registration Number: NCT01120834

Locations: 🇺🇸
Weill Cornell Medical College, New York, New York, United States

Azacitidine and Entinostat in Treating Patients With Metastatic Colorectal Cancer

Phase 2

Completed

Conditions: Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IV Colon Cancer
Stage IV Rectal Cancer

Interventions: Drug: entinostat
Drug: azacitidine
Other: laboratory biomarker analysis

First Posted Date: 2010-04-16

Last Posted Date: 2014-08-01

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 47

Registration Number: NCT01105377

Locations: 🇺🇸
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

and more 11 locations

Midostaurin and Azacitidine in Treating Elderly Patients With Acute Myelogenous Leukemia

Phase 1

Completed

Conditions: Untreated Adult Acute Myeloid Leukemia

Interventions: Drug: midostaurin
Drug: azacitidine
Other: bone marrow aspiration
Other: mutation analysis
Other: Pharmacokinetic study

First Posted Date: 2010-03-26

Last Posted Date: 2022-06-30

Lead Sponsor: Brenda Cooper, MD

Target Recruit Count: 34

Registration Number: NCT01093573

Locations: 🇺🇸
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
🇺🇸
West Virginia University, Morgantown, West Virginia, United States

Azacitidine in Treating Patients With Relapsed Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant

Phase 2

Completed

Conditions: Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Childhood Myelodysplastic Syndromes
Adult Acute Myeloid Leukemia With Del(5q)
Recurrent Childhood Acute Myeloid Leukemia
Chronic Myelomonocytic Leukemia
Previously Treated Myelodysplastic Syndromes
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)

Interventions: Drug: azacitidine
Other: laboratory biomarker analysis

First Posted Date: 2010-03-10

Last Posted Date: 2017-05-24

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 43

Registration Number: NCT01083706

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)

Phase 3

Completed

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Azacitidine
Drug: Conventional Care Regimen

First Posted Date: 2010-02-24

Last Posted Date: 2017-08-29

Lead Sponsor: Celgene

Target Recruit Count: 488

Registration Number: NCT01074047

Locations: 🇧🇪
Grand Hôpital de Charleroi, Charleroi, Hainaut, Belgium
🇦🇹
Wilhelminenspital, I Medizinische Abt., Wien, Vienna, Austria
🇵🇱
Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku, Wroclaw, Dolnoslaskie, Poland

and more 109 locations

Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) in Combination With Azacitidine for the Treatment of Myelodysplastic Syndrome (MDS)

Phase 1

Completed

Conditions: Myelodysplastic Syndromes

Interventions: Drug: G-CSF
Drug: Plerixafor
Drug: Azacitidine

First Posted Date: 2010-02-09

Last Posted Date: 2017-03-20

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 28

Registration Number: NCT01065129

Locations: 🇺🇸
Washington University School of Medicine, St. Louis, Missouri, United States

Lenalidomide + Azacitidine for Adaptive Immunotherapy -> Auto SCT in Multiple Myeloma

Not Applicable

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Azacitidine

First Posted Date: 2010-01-15

Last Posted Date: 2018-06-26

Lead Sponsor: Virginia Commonwealth University

Target Recruit Count: 17

Registration Number: NCT01050790

Locations: 🇺🇸
Virginia Commonwealth University, Richmond, Virginia, United States

Evaluation of Azacitidine in Transfusion Dependent Patients With Low-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML)

Phase 2

Completed

Conditions: Myelodysplastic Syndrome
Chronic Myelomonocytic Leukemia

Interventions: Drug: Azacitidine
Drug: Erythropoetin

First Posted Date: 2010-01-13

Last Posted Date: 2013-10-29

Lead Sponsor: Nordic MDS Group

Target Recruit Count: 30

Registration Number: NCT01048034

Locations: 🇩🇰
Department of Hematology, Aarhus Univsersity Hospital, Aarhus, Denmark
🇸🇪
Department of Hematology, Linköping University Hospital, Linköping, Sweden
🇸🇪
Department of medicine, Falun Hospital, Falun, Sweden

and more 14 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy